Haematologica 2003 - Supplements

in 5 pts (11%), M protein decreased by 90% - < CR, 75% - <
90%, 50% - 60, 43 %; B2M > 3,0 mg/L, 56 %; CRP > 3,0
mg/L, 14 %; and prior standard therapy > 12 mo, 72 %.
Results: We observed 4 % CR, 68 % PR, and 12 % of patients
with a minor response; total response rate 84 %
(EBMT/IBMTR/ABMTR criteria). Based on an intention-to-treat
analysis event-free survival was 11 months with an overal
survival of 19 months. No single disease characteristic at baseline
was predictive for response or survival at 1 years, however
cytogenetics and plasma cell labeling index were not available for
all patients. Following chemotherapy, 67 % of patients
experienced grade 4 neutropenia during at least one treatment
cycle; 9 % grade 4 thrombocytopenia. There were 26 % grade 3/4
infections; two early deaths due to neutropenic infection after the
first treatment cycle. Presumably thalidomide related side effects
included neuropathy (40 % grade 2; 16 % grade 3), 17 % grade 2
constipation, 5 % edema, 5 % bradycardia, 3 % skin reaction, and
5 patients (8 %) with deep vein thrombosis (DVT). DVTs were
not related to known thrombophilic risk factors.
Conclusion: Although highly effective in relapsed or refractory
myeloma, efficacy and tolerability of the HyperCDT regimen will
have to be compared to thalidomide/dexamethasone combined
with oral cyclophosphamide at an either continuous low-dose
(García-Sanz et al, 2002) or hyperfractionated intermediate-dose
schedule (Dimopoulos et al, 2001).
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Discordant response or progression in patients with
refractory myeloma treated with thalidomide based
regimens.
Athanasios Anagnostopoulos, George Hamilos, Vasiliki
Grigoraki, Meletios Athanasios Dimopoulos*
*Department of Clinical Therapeutics, University of Athens School
of Medicine tel: ++30210-3381-541, fax ++30210-8131-383 email:
mdimop@med.uoa.gr
Response to treatment in secretory myeloma is most commonly
assessed with the reduction of the paraprotein levels. This usually
correlates with reciprocal reduction of the bone marrow plasma
cells and the size of extramedullary sites. Thalidomide based
regimens (TBR) are now widely used for the treatment of
refractory multiple myeloma and have shown significant activity in
newly diagnosed patients. In some patients, we observed
discrepancies between the reduction of the paraprotein levels and
the plasma cell infiltrate in the bone marrow and/or extramedullary
sites after treatment with TBR. The purpose of this study was the
assessment of the incidence and analysis of this phenomenon in all
myeloma patients treated with TBR in our Institution.
Patients and methods: We studied responses and pattern of
progression of all patients who received TBRs and had a follow
up time of at least 6 months. Partial response (PR) was defined as
at least >50% reduction of serum myeloma protein production
and/or >90% reduction of Bence Jones protein excretion and
minor response a >25% reduction of the serum myeloma protein.
Relapse was defined as the earliest of >25% increase of myeloma
protein from lowest level, new lytic bone lesions, marrow
plasmacytosis to >10% or hypercalcemia.
Results: Between 7/99 and 7/02 we treated 93 patients with
refractory or relapsed myeloma with TBR. Fifty-six patients
(60%) achieved either partial or minor response. Three of them
(3%) had at least 25% reduction of the paraprotein levels (1
had>50% reduction) but at the time of best response the bone
marrow was still infiltrated with plasma cells (PC) [from 25%
(prior to treatment PC) → to 90% (post treatment PC),
85%→80% and 40%→50% in each of the 3 cases respectively].
Four additional patients (4%) after achieving a PR (3 of them
with >75% reduction of serum paraprotein) which lasted between
5 and 7 months, relapsed with bone marrow plasmacytosis (all
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